ClearanceBrief
510(k) K971221 ยท GIM Tubes, Vacuum Sample, With Anticoagulant

GREINER VACUETTE BLOOD COLLECTION TUBE

ApplicantGreiner America, Inc., Lake Mary FL, US
DecisionSubstantially Equivalent, May 2, 1997
ReceivedApr 2, 1997
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K971221

DateFirm and productCodeLinked 510(k)
Oct 28, 2025Greiner Bio-One North America, Inc.
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Open, Classified		 GIMNone listed
Aug 20, 2021Greiner Bio-One North America, Inc.
Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
Terminated		 GIMNone listed
May 6, 2021Greiner Bio-One North America, Inc.
VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole
Terminated		 GIMNone listed
Mar 12, 2020Greiner Bio-One North America, Inc.
VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
Terminated		 GIMNone listed
Aug 7, 2012Greiner Bio-One North America, Inc.
3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.
Terminated		 GIMNone listed
Sep 13, 2006Greiner Bio-One North America, Inc.
Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24 racks of 50, 1200 pcs in total * non-ridged * Sandwich Tube * 454332 * B050609 * 2007-05 * Ste
Terminated		 GIMNone listed
Aug 10, 2004Greiner VACUETTE North America
Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 24 racks of 50, 1200 pcs in total, non ridged, sandwich tube, Ref: 454332, Lot B040404, Expiry 2005-04, Sterile
Terminated		 GIMNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.